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Comorbidity-Based Propranolol Use in Pediatric Migraine

Targeting The Right Pediatric Migraine Patient: A Comorbidity-Oriented Approach To Propranolol Prophylaxis

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07103031
Enrollment
488
Registered
2025-08-05
Start date
2021-01-01
Completion date
2023-12-31
Last updated
2025-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Migraine Disorders, Brain, Pediatric Migraine, Vitamin D Deficiency

Keywords

Propranolol, Pediatric Migraine, Migraine Prophylaxis, Vitamin D Deficiency

Brief summary

This observational retrospective cohort study aims to identify clinical and biochemical predictors of response to propranolol prophylaxis in pediatric migraine. A total of 178 children diagnosed with migraine between 2021 and 2023 were evaluated based on headache-related disability (PedMIDAS) and pain severity (VAS). Patients were treated either with behavioral therapy or propranolol (1-3 mg/kg/day) for 3 months.

Detailed description

Migraine is a common and disabling neurological condition in the pediatric population, often requiring prophylactic treatment to reduce attack frequency and improve quality of life. Propranolol is frequently prescribed for pediatric migraine prevention; however, treatment response varies considerably among individuals. Understanding the clinical and biochemical factors that predict treatment efficacy could enhance individualized care and reduce unnecessary medication use. This retrospective cohort study evaluated 178 children diagnosed with pediatric migraine between January 2021 and December 2023 at a tertiary neurology outpatient clinic. All participants were assessed using the Pediatric Migraine Disability Assessment Scale (PedMIDAS) and Visual Analog Scale (VAS) before and after treatment. Patients received either behavioral therapy or oral propranolol (1-3 mg/kg/day) for a duration of 3 months, based on clinical indication and family preference.

Interventions

BEHAVIORALBehavioral therapy

Patients in PedMIDAS stage 1-2 (score ≤ 30) received behavioral therapy including lifestyle counseling, stress management techniques, sleep hygiene education, and individualized headache triggers review. Additionally, each patient was provided with a headache report card to self-monitor symptoms, triggers, and medication use over a 3-month period.

DRUGPropranolol

Patients in PedMIDAS stage 3-4 (score \> 30) received oral propranolol treatment at a dose of 1-3 mg/kg/day, adjusted by weight and tolerance, for a total of 3 months. The medication was prescribed and monitored by a pediatric neurologist. Patients were followed with routine check-ups and adverse effects were recorded.

Sponsors

Kayseri University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
2 Years to 19 Years
Healthy volunteers
No

Inclusion criteria

* Children aged 0-20 years * Diagnosed with primary headache according to the International Classification of Headache Disorders, 3rd edition (ICHD-3) * Clinical and/or neurological evaluation consistent with primary headache * Completed baseline PedMIDAS and VAS assessments * Available for 3-month follow-up after initiation of treatment

Exclusion criteria

* Diagnosis of secondary headache, based on clinical history, family history, neurological examination, or laboratory/imaging findings * Failure to meet ICHD-3 diagnostic criteria for primary headache * Presence of structural brain lesions or other neurological disorders * Chronic systemic illness or current use of other migraine prophylactic medications * Incomplete data or loss to follow-up within the 3-month period

Design outcomes

Primary

MeasureTime frameDescription
Pediatric Migraine Disability Assessment Scale (PedMIDAS) ScoreBaseline to 3 months after treatmentThe primary outcome is the change in PedMIDAS score from baseline to 3 months after treatment. PedMIDAS is a validated questionnaire that quantifies migraine-related disability in children and adolescents. A greater reduction indicates improved clinical response.

Secondary

MeasureTime frameDescription
Visual Analog Scale (VAS) Pain ScoresBaseline to 3 months after treatmentVAS pain scores range from 0 (no pain) to 10 (worst imaginable pain). The change in VAS score after 3 months of treatment reflects the patient's subjective pain improvement.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026